- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05609786
Dissemination and Implementation of a Web-based Relationship Safety App, myPlanKenya, for Women at Risk for Intimate Partner Violence in Nairobi, Kenya (myPlanKenya)
This effectiveness-implementation hybrid-3 study evaluates dissemination, implementation, and effectiveness of myPlanKenya. myPlanKenya will be disseminated through formal and informal sectors. This clinical trial portion of the study enrolls women at risk for intimate partner violence (IPV) who are referred to myPlanKenya by disseminators (i.e. "end-users").
This trial aims to evaluate the effectiveness of myPlanKenya referral on resilience, health and safety among a cohort of women referred to myPlanKenya based on disclosure of IPV or assessed to have IPV related risks.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Nairobi, Kenya
- Ujamaa Africa
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Female
- Age 16 or older
- Physical or sexual partner violence or relationship-based fears within the past six months; behaviorally assessed
- Living in Nairobi, Kenya with no plans to move in the next 12 months
- Access to a safe smart phone or computer (personal or shared), and comfort using it to access the myPlan Kenya app
- Literate in English or Swahili languages; confirmed by reading and completing a short passage by filling in several blanks with the appropriate words, selected from a drop-down menu.
Exclusion Criteria:
- Male
- Under age 16
- Have not experienced physical or sexual partner violence or relationship-based fears in past 6 months
- Lives outside of the study area or plans to move within the next 12 months
- Does not have access to a safe smart phone or computer, or is uncomfortable using it to access the myPlan Kenya app
- Illiterate in English or Swahili languages
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: myPlan Kenya
myPlan Kenya web-based application
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The myPlan Kenya app is a web-based safety planning tool that is secure, private, free and personalized to the user.
The app includes multiple, evidence-based modules: Strategies (safety strategies tailored to the user's needs and violence experience); Resources (referrals to local health, safety and justice resources and services); About You (questionnaires that help the user assess their relationship safety and tailor their Strategies, including My Relationship, Red Flags, My Safety, My Priorities); Understanding (knowledge sections that share information on relationships and violence, including Healthy Relationships, Harmful Beliefs About Abuse, About Violence).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resilience as Assessed by Connor-Davidson Resilience Scale
Time Frame: Baseline, 6-month, 12-month
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10-item Connor-Davidson Resilience Scale assesses resilience using a 5-point Likert scale (0-4).
Scored from 0-40, with higher scores indicating greater resilience and lower scores indicating lower resilience.
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Baseline, 6-month, 12-month
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Decisional Conflict Score
Time Frame: Baseline, 6-month, 12-month
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12-item decisional conflict measures (specific to safety), assessed using a 5-point Likert scale (0-4).
The mean Decisional Conflict score is multiplied by 25 to create an overall score, ranging from 0-100; 0 (no decisional conflict) to 100 (extremely high decisional conflict).
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Baseline, 6-month, 12-month
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Safety/IPV Experience(s) as Assessed by the Conflict Tactics Scale-2
Time Frame: Baseline, 6-month, 12-month
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10-item adapted Conflict Tactics Scale-2 (CTS2), which assesses IPV experiences using a 3-point scale on the frequency of these experiences.
Score range 0-20; higher score indicates more IPV.
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Baseline, 6-month, 12-month
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Percentage of Participants Who Sought Services (Help-seeking)
Time Frame: Baseline, 6-month, 12-month
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6-item index on help-seeking, which assesses abuse disclosure and services/information received on a 2-point scale (yes/no); operationally defined as percentage of participants who sought help from any of the services.
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Baseline, 6-month, 12-month
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Helpfulness of Services Assessed by Help-Seeking Index
Time Frame: Baseline, 6-month, 12-month
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6-item index on help-seeking which assesses abuse disclosure and services/information. Helpfulness of services rated on a 5-point Likert scale (Score range 0-4; with higher score more helpful).
Mean helpfulness score of services sought is reported.
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Baseline, 6-month, 12-month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety Strategy Score
Time Frame: Baseline, 6-month, 12-month
|
5-item index on safety strategies used (yes/no), summed for a range of 0-5 with higher scores indicating more safety strategies used.
For each strategy used, helpfulness is assessed on a 5-point Likert scale (1-5), with higher scores indicating more helpfulness; mean scores are presented (range 1-5).
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Baseline, 6-month, 12-month
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IPV Recognition as Assessed by the Abusive Behaviors Scale
Time Frame: Baseline, 6-month, 12-month
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7-item adapted Abusive Behaviors Scale, which assesses IPV recognition using a 5-point Likert scale (0-4).
Items are scored from 0-28, with higher scores indicating greater IPV recognition and lower scores indicating lower IPV recognition.
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Baseline, 6-month, 12-month
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Michele Decker, Johns Hopkins Bloomberg School of Public Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00017456
- R01HD099144 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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